RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to
light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells
and, when exposed to light, become active and kill the tumor cells.
PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in
treating patients who have non-small cell lung cancer.
- Determine the systemic and normal tissue toxicity of photodynamic therapy with HPPH in
patients with early stage or centrally obstructing non-small cell lung cancer.
- Determine, preliminarily, the efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of HPPH.
Patients receive HPPH IV over 1 hour on day 1. Patients undergo laser light therapy via
bronchoscopy on day 3.
Cohorts of 3-6 patients receive escalating doses of HPPH until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.
Patients are followed for at least 6 months.
PROJECTED ACCRUAL: Approximately 15-17 patients will be accrued for this study within 2
- Histologically confirmed microinvasive or centrally obstructing non-small cell lung
- Squamous cell carcinoma
- Large cell carcinoma
- 18 and over
- Karnofsky 50-100% OR
- ECOG 0-2
- Not specified
- WBC at least 2,000/mm^3
- Platelet count at least 50,000/mm^3
- Bilirubin no greater than 3.0 mg/dL
- Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)
- SGOT no greater than 3 times ULN
- PT no greater than 1.5 times ULN
- Creatinine no greater than 3.0 mg/dL
- No severe chronic obstructive pulmonary disease that would preclude study
- Not pregnant
- Fertile patients must use effective contraception
- No contraindications to bronchoscopy
- No porphyria
- No hypersensitivity to porphyrin or porphyrin-like compounds
PRIOR CONCURRENT THERAPY:
- Prior biologic therapy for lung cancer allowed
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
- Prior endocrine therapy for lung cancer allowed
- At least 4 weeks since prior radiotherapy
- No concurrent external beam radiotherapy
- No concurrent surgery
- Prior therapy for lung cancer allowed